Active Ingredient(S)
Glycerin、Propylene Glycol、Menthol、1,2-Hexanediol、Hydroxyacetophenone
Numbing Cream
FDA Label NDC 84983-039
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou South Moon Biotechnology Co., Ltd. for the product Numbing Cream (NDC 84983-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, stop use, ask a doctor before use if you, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Temporarily relieves pain and discomfort.
Use
1. Clean and dry the desired area thoroughly.
2. Apply a thick layer of cream evenly over the area.
3. Cover with plastic wrap.
4. Leave on for 30-60 minutes for optimal effect.
5. Remove excess cream before beginning the procedure
Warnings
For external use only.
Do Not Use
In large quantities over raw or blistered skin.
On deep puncture wounds or serious burns.
If allergic to lidocaine or any ingredient in this product.
Stop Use
In large quantities over raw or blistered skin.
On deep puncture wounds or serious burns.
If allergic to lidocaine or any ingredient in this product.
Ask A Doctor Before Use If You
Have heart disease.
Have liver disease.
Are pregnant or breastfeeding.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
If swallowed, seek medical help immediately or contact a Poison Control Center.Children under 12 years old should use only under adult supervision or medical advice.
Storage And Handling
Store at room temperature (15-30°C/59-86°F).
Avoid direct sunlight and excessive heat.
Do not use if packaging is damaged or seal is broken.
Inactive Ingredient
Water、Mineral Oil、Carbomer、Glyceryl Stearate、Triethanolamine
Indications & Usage
Clean and dry affected area thoroughly.
Apply a thin, even layer of cream to the skin.
Allow absorption before covering or proceeding with procedure.
Reapply only as needed, not exceeding 3-4 applications per day.
Dosage & Administration
Clean and dry affected area thoroughly.
Apply a thin, even layer of cream to the skin.
Allow absorption before covering or proceeding with procedure.
Reapply only as needed, not exceeding 3-4 applications per day.
Package Label.Principal Display Panel
Label (Dsku 00002847)
* Please review the disclaimer below.
